Integrated loading and storage system for implantable medical devices

ABSTRACT

A loading device includes a locking collar assembly including a proximal end, a distal end, and a loading channel formed between the proximal end and the distal end. The device also includes a loading funnel coupled to the distal end of the locking collar assembly at a proximal end of the loading funnel. The loading funnel is configured to store a collapsible medical device in a partially collapsed state within a tapered interior volume of the loading funnel. The tapered interior volume decreases in volume from a distal end of the loading funnel to the proximal end of the loading funnel.

FIELD

The present technology is generally related to loading and storagesystems for medical devices.

BACKGROUND

Currently, implantable medical devices, such as stents, scaffolds, andother cardiac intervention devices that contain organic tissue, e.g.,bovine and porcine, require onsite installation onto a delivery device.This is due to the need to store the implantable devices in conditionsspecific to preserve the organic tissue. Typically, a detailed processmust be performed in order to install a medical device on a deliverydevice. The detailed process, however, can be cumbersome and costly dueto the potential of damaging the implantable medical device during theinstallation.

SUMMARY

The techniques of this disclosure generally relate to a combinationstorage and loading system for loading an implantable medical deviceonto a delivery device and converting the implantable medical devicefrom an uncompressed state to a compressed state.

In one aspect, the disclosure provides a device for storing medicaldevices and loading the medical devices onto delivery devices. Thedevice includes a locking collar assembly including a proximal end, adistal end, and a loading channel formed between the proximal end andthe distal end. The device also includes a loading funnel coupled to thedistal end of the locking collar assembly at a proximal end of theloading funnel. The loading funnel is configured to store a collapsiblemedical device within a tapered interior volume of the loading funnel ina partially collapsed state. The tapered interior volume decreases involume from a distal end of the loading funnel to the proximal end ofthe loading funnel. The device includes a retainer positioned with theloading channel at the distal end of the locking collar assembly andincludes a connector configured to couple to a delivery device. Thecollapsible medical appliance is coupled to the retainer. The retainermaintains the collapsible medical device within the loading funnel priorto connection to the delivery device. The device further includes anosecone pin coupled to the retainer and positioned within the taperedinterior volume of the loading funnel. Additionally, the device includesa storage jar coupled to a distal end of the loading funnel. The storagejar is configured retain the collapsible medical device and the noseconepin within the tapered interior volume of the loading funnel.

In another aspect, the present disclosure provides a device for storingmedical devices and loading the medical devices onto delivery devices.The device includes a locking collar assembly including a proximal end,a distal end, and a loading channel formed between the proximal end andthe distal end. The device also includes a loading funnel coupled to thedistal end of the locking collar assembly at a proximal end of theloading funnel. The loading funnel is configured to store a collapsiblemedical device in a partially collapsed state within a tapered interiorvolume of the loading funnel. The tapered interior volume decreases involume from a distal end of the loading funnel to the proximal end ofthe loading funnel. Further, the device includes a retainer positionedwith the loading channel at the distal end of the locking collarassembly and includes a connector configured to couple to a deliverydevice. The collapsible medical device is coupled to the retainer. Theretainer maintains the collapsible medical device within the loadingfunnel prior to connection to the delivery device. The device includes anosecone pin coupled to the retainer and positioned within the taperedinterior volume of the loading funnel. Additionally, the device includesa funnel cap coupled to the distal end of the loading funnel. The funnelcap is configured retain the collapsible medical device and the noseconepin within the tapered interior volume of the loading funnel.

In another aspect, the disclosure provides a method for storing medicaldevices and loading the medical devices onto delivery devices. Themethod includes washing, with a sterile solution, a collapsible medicaldevice that is stored within a tapered interior volume of a loadingdevice in a partially collapsed state. The method also includes couplinga delivery device to a retainer positioned within the loading device.The retainer maintains the collapsible medical device within the loadingdevice in the partially collapsed state prior to connection to thedelivery device. Additionally, the method includes retracting theretainer through a loading channel of the loading device, whereretracting retainer causes the collapsible medical device to movethrough the tapered interior volume to compress the collapsible medicaldevice. The method includes removing the loading device from thedelivery device. The method also includes sealing the collapsiblemedical device within the delivery device.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the techniques described in this disclosurewill be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and advantages of the presentdisclosure will be apparent from the following description ofembodiments hereof as illustrated in the accompanying drawings. Theaccompanying drawings, which are incorporated herein and form a part ofthe specification, further serve to explain the principles of thepresent disclosure and to enable a person skilled in the pertinent artto make and use the embodiments of the present disclosure. The drawingsare not to scale.

FIG. 1A depicts a perspective illustration of a loading system for usewith a medical device, according to an embodiment hereof.

FIG. 1B depicts a cross-sectional illustration of the loading system ofFIG. 1A, according to an embodiment hereof.

FIGS. 2A-2C depict several illustrations of a locking collar assembly ofthe loading system of FIGS. 1A and 1B, according to an embodimenthereof.

FIGS. 3A and 3B depict illustrations of a loading funnel of the loadingsystem of FIGS. 1A and 1B, according to an embodiment hereof.

FIGS. 4A and 4B depict illustrations of a funnel cap of the loadingsystem of FIGS. 1A and 1B, according to an embodiment hereof.

FIGS. 5A and 5B depict illustrations of a device retainer of the loadingsystem of FIGS. 1A and 1B, according to an embodiment hereof.

FIG. 6 depicts an illustration of a nosecone pin of the loading systemof FIGS. 1A and 1B, according to an embodiment hereof.

FIG. 7 depicts an illustration of a storage of the loading system ofFIGS. 1A and 1B, according to an embodiment hereof.

FIG. 8 depicts a flowchart of a process for the operation of the loadingsystem of FIGS. 1A and 1B, according to an embodiment hereof.

FIGS. 9A-91 depict several illustrations of the operation of the loadingsystem of FIGS. 1A and 1B, according to an embodiment hereof.

FIG. 10A depicts a perspective illustration of another loading systemfor use with a medical device, according to an embodiment hereof.

FIG. 10B depicts a cross-sectional illustration of the loading system ofFIG. 10A, according to an embodiment hereof.

FIGS. 11A and 11B depict illustrations of a locking collar of theloading system of FIGS. 10A and 10B, according to an embodiment hereof.

FIGS. 12A and 12B depict illustrations of a cap of the loading system ofFIGS. 10A and 10B, according to an embodiment hereof.

FIGS. 13A and 13B depict illustrations of a loading funnel of theloading system of FIGS. 10A and 10B, according to an embodiment hereof.

FIGS. 14A-14C depict several illustrations of a storage jar of theloading system of FIGS. 10A and 10B, according to an embodiment hereof.

FIGS. 15A and 15B depict illustrations of a fluid port of the loadingsystem of FIGS. 10A and 10B, according to an embodiment hereof.

FIG. 16 depicts a flowchart of a process for the operation of theloading system of FIGS. 10A and 10B, according to an embodiment hereof.

FIGS. 17A-17I depict several illustrations of the operation of theloading system of FIGS. 10A and 10B, according to an embodiment hereof.

DETAILED DESCRIPTION

Specific embodiments of the present disclosure are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements.

The following detailed description describes examples of embodiments andis not intended to limit the present technology or the application anduses of the present technology. Although the description of embodimentshereof is in the context of a storage and loading device for aprosthetic heart valve, the present technology may also be used forother devices. Furthermore, there is no intention to be bound by anyexpressed or implied theory presented in the preceding technical field,background, brief summary or the following detailed description.

Embodiments of disclosed herein are directed to a loading system forstoring an implantable medical device and loading the implantablemedical device onto a delivery device. In embodiments, the loadingsystem stores the medical device, e.g., a prosthetic heart valve, in apartially compressed or “loaded” state. The loading system stores themedical device in a preserving fluid to enable the medical device to bestored for a period of time without degrading the medical device. Whenthe medical device is ready to be implanted, the loading system isattached to a delivery device. The loading system enables the medicaldevice to be loaded in the delivery device without direct interactionwith the medical device. As such, the loading system can provide forstoring and loading implantable medical devices at a reduced cost and ina portable fashion. The integrated design of the loading system reducesthe steps to clean, sterilize, and load the implantable medical device.

FIGS. 1A and 1B illustrate an example of a loading system 100 inaccordance with an embodiment hereof. One skilled in the art willrealize that FIGS. 1A and 1B illustrate one example of a loading systemand that existing components illustrated in FIGS. 1A and 1B may beremoved and/or additional components may be added to the loading system100.

As illustrated in FIG. 1A, the loading system 100 includes a lockingcollar assembly 102, which includes a split collar 104 and a lockingcollar 106. The loading system 100 also includes a loading funnel 108and a funnel cap 110. As illustrated in FIG. 1B, the locking collarassembly 102 also includes a device retainer 112 and a nosecone pin 114.When coupled to the loading system 100, the device retainer 112 ispositioned within the locking collar 106 of the locking collar assembly102. The nosecone pin 114 is coupled to the device retainer 112 andextends through the loading funnel 108.

The device retainer 112 is coupled to an implantable medical device 116.In embodiments, any type of implantable medical device that requires aconversion from an uncompressed state to a compressed state and thatrequires loading onto a delivery device can be utilized with the loadingsystem 100. In an embodiment, the implanted medical device 116 caninclude components that are intended to repair or support systems of thehuman body, e.g., prosthetic heart valves including organic tissuecoupled to self-expandable or balloon-expandable stents/frames. Forexample, the loading system 100 can be utilized on implantable medicaldevices that are to be delivered transluminally, e.g., via a catheter,and need to be loaded onto or into a catheter. The stent/frame may beradially compressed to have a low profile and loaded into/onto adelivery device such that the heart valve prosthesis can be deliveredthrough the vessels to a target location in a compressed state, and thenexpanded at the target location, by a self-expanding stent/frame or aballoon of the delivery device, for instance, to replace the nativeheart valve.

The loading system 100 is configured to store the implantable medicaldevice 116 in a partially compressed or “loaded” state. That is, theloading funnel 108 is configured to apply a force to the implantablemedical device 116 to partially compress the implantable medical device116 and maintain the implantable medical device 116 in the partiallycompressed state during storage. In embodiments, as further describedbelow, the loading funnel 108 is formed with a tapered interior chamberthat maintains the implantable medical device 116 in a partiallycompressed state and operates to further compress the implantablemedical device 116 when loading the implantable medical device 116 ontoa delivery device.

The locking collar assembly 102 enables a delivery device, e.g.,catheter, to be attached to device retainer 112 with minimal interactionwith the implantable medical device 116. In an embodiment, as furtherdescribed below, a delivery device (or component of the delivery device)is inserted into the locking collar assembly 102 and attached to thedevice retainer 112. To load the implantable medical device 116, thedevice retainer 112 is retracted into the delivery device. As the deviceretainer 112 is retracted, the implantable medical device 116 is furthercompressed by the loading funnel 108.

FIGS. 2A-2C illustrate an example of the locking collar assembly 102 inaccordance with an embodiment hereof. One skilled in the art willrealize that FIGS. 2A-2C illustrate one example of a locking collarassembly and that existing components illustrated in FIGS. 2A-2C may beremoved and/or additional components may be added to the locking collarassembly 102.

As illustrated in FIG. 2A, the split collar 104 includes a first collarhalf 202 and a second collar half 204. The first collar half 202 and thesecond collar half 204, when joined, form a proximal opening 206, adistal opening 208, and a loading channel 212. The loading channel 212is formed in an approximate cylindrical shape with circularcross-section having an inner diameter, d₁. The loading channel 212 isformed with the diameter, d₁, to accommodate the device retainer 112 andallow the insertion of a delivery device, e.g., a catheter, into thesplit collar 104. In embodiments, the diameter, d₁, of the loadingchannel 212 may depend on the French (FR) size of the catheter. Forexample, the diameter, d₁, of the loading channel 212 may be formed toaccommodate a 18-33 Fr catheter. In an embodiment, the delivery devicemay be inserted into the proximal opening 206, and the device retainer112 may be positioned at or near the distal opening 208. The splitcollar 104 can be formed of any suitable material such as, but notlimited to a polymeric material.

For example, the loading system 100 may be configured to store and loada 42 millimeter (mm) transcatheter mitral valve replacement device(TMVR), e.g., heart valve and frame. In such as embodiment, the loadingchannel 212 may be formed with a diameter, d₁, in a range ofapproximately 6 mm to approximately 13 mm. In another example, theloading system 100 may be configured to store and load a 48 mm TMVRdevice. In such an embodiment, the loading channel 212 may be formedwith a diameter, d₁, in a range of approximately 6 mm to approximately13 mm. One skilled in the art will realize that the loading channel 212can be formed to any dimension and/or cross-sectional shape toaccommodate different medical devices and or delivery devices.

The first collar half 202 and the second collar half 204 include tabs214. The tabs 214 can be configured to provide a connection and/orinterface point to the loading funnel 108. The tabs 214 allow fluid toenter an interior space of the split collar 104 and allow air to exitinterior space of the split collar 104. This may prevent air does frombecoming trapped between the implantable medical device 116 and thedelivery device.

The first collar half 202 and the second collar half 204 includeconnector pins 216 and connector holes 218. The connector pins 216 arealigned with the connector holes 218 to engage with the connector holes218 when the first collar half 202 and the second collar half 204 arejoined to form the split collar 104. The split collar 104 includes thefirst collar half 202 and the second collar half 204 to allow the spiltcollar 104 to be separated and removed once the implantable medicaldevice 116 is loaded into the delivery device.

As illustrated in FIG. 2B, the split collar 104 also includes a circularridge 220 positioned adjacent to and/or near the distal opening 208. Thecircular ridge 220 extends radially inward from the inner surface of thesplit collar 104. In an embodiment, the circular ridge 220 can be formedin an approximate ring and/or torus shape. The circular ridge 220 isformed to a diameter, d₂, that is smaller than the diameter, d₁, of theloading channel 212. In an embodiment, the circular ridge 220 can beformed to a diameter, d₂, that is larger than the diameter of the deviceretainer 112, but smaller than the outer diameter of the deliverydevice, for example, an outer shaft of the delivery device, to beinserted into the locking collar 104. In this embodiment, the circularridge 220 can function to prevent the implantable medical device 116from contacting contact with the delivery device during loading, i.e.,provides protection for the implantable medical device 116 duringloading.

The split collar 104 includes male threads 210 are formed on an outersurface of the split collar 104 and are positioned at or near the distalopening 208. The male threads 210 are configured to engage femalethreads 256 (illustrated in FIG. 2C) of the locking collar 106 andsecure the split collar 104 to the locking collar 106. The femalethreads 256 are formed on an inner surface of the locking collar 106 andare positioned along an entire length of the inner surface of thelocking collar 106. As described herein, a “female” threads and/orconnectors are generally receptacles that receive and hold “male”threads and/or connectors. Once the locking collar 106 is secured to thesplit collar 104, the locking collar 106 applies a force to the firstcollar half 202 and the second collar half 204 to hold the first collarhalf 202 and the second collar half 204 together.

While FIGS. 2A-2C illustrate threads for coupling the split collar 104and the locking collar 106, one skilled in the art will realize thatother types of connectors can be utilized to mechanically couple thesplit collar 104 and the locking collar 106. In some embodiments, thesplit collar 104 and the locking collar 106 can include a push fitlocking collar that acts as an interference fit for coupling the splitcollar 104 and the locking collar 106. For example, an outer diameter ofthe split collar 104 may be larger than an inner diameter of the lockingcollar 106. In some embodiments, the split collar 104 and the lockingcollar 106 can include a c-clip mechanism connector that acts as amechanical interference between the split collar 104 and the lockingcollar 106. In some embodiments, the split collar 104 and the lockingcollar 106 can include a snap fit connection (e.g., cantilever,torsional and/or annular). For example, the split collar 104 can includea protruding edge or tab, and the locking collar 106 can include asnap-in area (e.g., groove, channel, etc.) for receiving and locking theprotruding edge or tab. Likewise, for example, the locking collar 106can include a protruding edge or tab, and the split collar 104 caninclude a snap-in area (e.g., groove, channel, etc.) for receiving andlocking the protruding edge or tab.

As illustrated in FIGS. 2A and 2C, the locking collar 106 includes afirst end 250 and a second end 252. The locking collar 106 includesexternal ridges 254. The external ridges 254 can provide a texturedsurface to assist in the securing of the locking collar 106 to the splitcollar 104. The locking collar 106 can be formed of any suitablematerial such as, but not limited to a polymeric material.

FIGS. 3A and 3B illustrate an example of the loading funnel 108 inaccordance with an embodiment hereof. One skilled in the art willrealize that FIGS. 3A and 3B illustrate one example of a loading funneland that existing components illustrated in FIGS. 3A and 3B may beremoved and/or additional components may be added to the loading funnel108.

As illustrated in FIG. 3A, the loading funnel 108 includes a funnel body302 with a proximal end 304 and a distal end 306. The funnel body 302 isformed in an approximate conical shape with the proximal end 304 havinga smaller diameter than the distal end 306. The loading funnel 108includes male threads 308 formed on an outer surface of the loadingfunnel at the distal end 306 of the funnel body 302. The male threads308 are configured to engage with female threads of the funnel cap 110,described below. The funnel body 302 can be formed on any suitablematerial such as, but not limited to stainless steel.

As illustrated in FIGS. 3A and 3B, the loading funnel 108 includes aproximal opening 310 formed in the proximal end 304 of the funnel body302 having a diameter, f₁. The loading funnel 108 also includes a distalopening 312 formed in the distal end 306 of the funnel body 302 having adiameter, f₂. The interior of the funnel body 302 forms a compressionvolume 311. The compression volume 311 is formed in an approximatefunnel or cone shape with a decreasing volume from the distal end 306 tothe proximal end 304 of the funnel body. In an embodiment, thecompression volume 311 is tapered, in a decreasing diameter, fromdiameter, f₂, at the distal end 306 to the diameter, f₁, at the proximalend 304. The compression volume 311 can be formed of a first funnelsection 314, a second funnel section 316, a third funnel section 318,and a fourth funnel section 320. Each of the first funnel section 314,the second funnel section 316, the third funnel section 318, and thefourth funnel section 320 can be formed in the shape of a funnel, eachwith a different degree of decreasing volume from the distal end 306 tothe proximal end 304. In embodiments, the volume of the compressionvolume 311 operates to maintain the implantable medical device 116 in apartially compressed state during storage.

In embodiments, the degree of decreasing volume, e.g., taper angle, canaffect the angle at which the implant attachment tabs exit the funnel,with a longer taper improving the loading of the implantable medicaldevice 116. The longer taper may provide a smoother transition for theimplantable medical device 116 during loading into the delivery device.A short taper may apply compressive strain on the implantable medicaldevice 116, may require high force during loading, may result in anuneven crimp, may cause inflooding of the implantable medical device116, or may apply an additional compressive load on the implantablemedical device 116 when stored. According the degree of decreasingvolume, e.g., taper angle, may be set to minimize these and ensureintegrity of the implantable medical device 116.

In embodiments, the decreasing volume of the compression volume 311operates to apply a compression force on the implantable medical device116 as device retainer 112 is retracted through the loading channel 212.That is, as the device retainer 112 is retracted into the deliverydevice positioned in the loading channel 212, the implantable medicaldevice 116 retracts in a loading direction, L, through the proximalopening 310. As the implantable medical device 116 moves through thecompression volume 311, the inner surfaces of the loading funnel body302 apply a compression force on surfaces of the implantable medicaldevice 116.

In embodiments, the diameter, f₁, of the proximal opening 310 may dependon the FR size of the catheter. For example, the diameter, f₁, of theproximal opening 310 may be formed to accommodate a 18-33 Fr catheter.In embodiments, the diameter, f₂, of the distal opening 312 may dependon an outer diameter of the implantable medical device 116.

In some embodiments, the loading system 100 may be configured to storeand load a 42 mm TMVR device, and In such an embodiment, the diameter,f₁, can be in a range of approximately 6 mm to approximately 13 mm, andthe diameter, f₂, can be in the range of approximately 20 mm toapproximately 60 mm. In another example, the loading system 100 may beconfigured to store and load a 48 mm TMVR device, and the proximalopening 310 may be formed with a diameter, f₁, and the distal opening312 may be formed with a diameter, f₂. In such an embodiment, thediameter, f₁, can be in a range of approximately 6 mm to approximately13 mm, and the diameter, f₂, can be in the range of approximately 20 mmto approximately 60 mm. One skilled in the art will realize that thecompression volume 311 can be formed to any dimension and/orcross-sectional shape to accommodate different medical devices and ordelivery devices.

FIGS. 4A and 4B illustrate an example of the funnel cap 110 inaccordance with an embodiment hereof. One skilled in the art willrealize that FIGS. 4A and 4B illustrate one example of a funnel cap andthat existing components illustrated in FIGS. 4A and 4B may be removedand/or additional components may be added to the funnel cap 110.

As illustrated in FIG. 4A, the funnel cap 110 includes a cap body 402and a nosecone pin housing 404. The cap body 402 can be formed in anapproximate cylindrical shape and includes cap indentations 406. Forexample, as illustrated in FIG. 4A, the cap body 402 can include four(4) cap indentations 406 positioned at opposing location around the capbody 402. The cap indentations 406 can provide a location to applyleverage when removing the funnel cap 110 from the loading funnel 108,as described below in further detail. The cap body 402 can be formed ofany suitable material such as, but not limited to a polymeric material.

The cap body 402 can also include female threads 408 formed on aninterior surface of the cap body 402. The female threads 408 can beformed to match and engage with the male threads 308 of the exteriorsurface of the loading funnel 108 to secure the funnel cap 110 to theloading funnel 108. The nosecone pin housing 404 can be formed in anapproximate cylindrical shape. The nosecone pin housing 404 isconfigured to hold the nosecone pin 114. That is, when the nosecone pin114 is stored within the loading system 100, the nosecone pin 114 abutsa bottom surface of the nosecone pin housing 404. The sidewalls of thenosecone pin housing 404 hold the nosecone pin 114 in position andprevent the nosecone pin 114 from moving laterally within the loadingsystem 100. The nosecone pin housing 404 can be formed of any suitablematerial such as, but not limited to a polymeric material.

As illustrated in FIGS. 4A and 4B, the cap body 402 and the nosecone pinhousing 404 includes port 410. The ports 410 can be configured to enablefluid to enter and exit the interior of the funnel cap 110. The funnelcap 110 operates to prevent the device retainer 112 and the implantablemedical device 116 from exiting the distal opening 312 of the loadingfunnel 108. That is, the nosecone pin housing 404 (e.g., bottom surface)applies a force on the nosecone pin 114, which is attached to the deviceretainer 112, to prevent the device retainer 112 and the implantablemedical device 116 from sliding distally out of the loading funnel 108due to compression force of the loading funnel 108 when the implantablemedical device 116 is in a partially compressed state.

While FIGS. 3A, 3B, 4A and 4B illustrate threads for coupling theloading funnel 108 and the funnel cap 110, one skilled in the art willrealize that other types of connectors can be utilized to mechanicallycouple the loading funnel 108 and the funnel cap 110. In someembodiments, the loading funnel 108 and the funnel cap 110 can include apush fit locking collar that acts as an interference fit for couplingthe loading funnel 108 and the funnel cap 110. For example, an outerdiameter of the loading funnel 108 may be larger than an inner diameterof the funnel cap 110. In some embodiments, the loading funnel 108 andthe funnel cap 110 can include a c-clip mechanism connector that acts asa mechanical interference between the loading funnel 108 and the funnelcap 110. In some embodiments, the loading funnel 108 and the funnel cap110 can include a snap fit connection (e.g., cantilever, torsionaland/or annular). For example, the loading funnel 108 can include aprotruding edge or tab, and the funnel cap 110 can include a snap-inarea (e.g., groove, channel, etc.) for receiving and locking theprotruding edge or tab. Likewise, for example, the funnel cap 110 caninclude a protruding edge or tab, and the loading funnel 108 can includea snap-in area (e.g., groove, channel, etc.) for receiving and lockingthe protruding edge or tab.

FIGS. 5A and 5B illustrate an example of the device retainer 112 inaccordance with an embodiment hereof. One skilled in the art willrealize that FIGS. 5A and 5B illustrate one example of a device retainerand that existing components illustrated in FIGS. 5A and 5B may beremoved and/or additional components may be added to the device retainer112.

As illustrated in FIG. 5A, the device retainer 112 includes a firstsection 502 formed at a proximal end of the device retainer 112 and athird section 506 formed at a distal end 509 of the device retainer 112.The device retainer 112 also includes a second section 504 formedbetween the first section 502 and the third section 506. The firstsection 502 is configured to be coupled to the delivery device, asdescribed in further detail below. The third section 506 is configuredto be coupled to the implantable medical device 116. The first section502, the second section 504, and the third section 506 are formed in acylindrical shape. The second section 504 can be formed to an externaldiameter that is smaller than the first second 502 and the third section506. In an embodiment, the second section 504 can operate as a channelto receive a sealing ring (e.g., o-ring). The sealing ring can operateto form hydraulic circuit in the delivery device as part of apressurized system which closes components of the delivery device (e.g.,capsule).

The device retainer 112 includes a fourth section 508 formed at thedistal end 509 of the device retainer 112. The fourth section 508includes locking channels 510, a distal opening 512, female threads 514,and ports 516. The locking channels 510 are configured to engage withthe implantable medical device 116. In an example, the locking channels510 may be T-shaped slots that are configured to receive T-shaped tabson the frame/stent of the implantable medical device 116. That is,T-shaped tabs on the implantable medical device 116 may be configured tolock into the T-shaped slots of the locking channels 510 to secure theimplantable medical device 116 to the device retainer 112. The ports 516allow an operator of the delivery device de-gas regions around theimplantable medical device 116 before and/or after the implantablemedical device 116 is loaded. For example, liquid may be injected into aport in a proximal end at the delivery device and exits thru ports 516.

The female threads 514 are formed on inner surfaces of the third section506 and the fourth section 508. The female threads 520 are configured toengage with male threads (e.g., male threads 616 as illustrated in FIG.6) of the nosecone pin 114 to secure the nosecone pin 114 to the deviceretainer 112. The device retainer 112 can be formed of any suitablematerial such as, but not limited to a polymeric material.

As illustrated in FIG. 5B, the device retainer 112 includes a proximalopening 518. The device retainer 112 includes female threads 520 from onan inner surface of the first section 502. The female threads 520 areconfigured to engage with male threads of the delivery device to securethe device retainer 112 to the delivery device.

FIG. 6 illustrates an example of the nosecone pin 114 in accordance withan embodiment hereof. One skilled in the art will realize that FIG. 6illustrates one example of a nosecone pin and that existing componentsillustrated in FIG. 6 may be removed and/or additional components may beadded to the nosecone pin 114.

As illustrated in FIG. 6, the nosecone pin 114 includes a first section602 formed at a distal end of the nosecone pin 114. The first section602 includes male threads 604 formed adjacent to and/or near the distalend of the nosecone pin 114. The male threads 604 are configured toengage with female threads of one or more devices that may be associatedwith the delivery device. For example, the male threads 604 can beconfigured to engage with female threads of a nosecone or cap that sealsthe delivery device once the implantable medical device 116 is loaded.The nosecone pin 114 can be formed of any suitable material such as, butnot limited to a polymeric material.

The nosecone pin 114 includes a second section 606 that is formedadjacent to the first section 602. The second section 606 is formed in acylindrical shape and includes a distal tapered edge 608 and a proximaltapered edge 610. The second section 606 is formed to a diameter thatmatches the delivery device, e.g., an outer shaft. The nosecone pin 114includes a third section 612 formed adjacent to the second section 606and a fourth section 614 formed adjacent to the third section 612. Thethird section 606 and the fourth section 614 are formed in a cylindricalshape. The fourth section 614 includes male threads 616 formed at adistal end of the nosecone pin 114. The male threads 616 are configuredto engage with the female threads 512 of the device retainer 112.

FIG. 7 illustrates an example of a storage jar 700 in accordance with anembodiment hereof. One skilled in the art will realize that FIG. 7illustrates one example of a storage jar and that existing componentsillustrated in FIG. 7 may be removed and/or additional components may beadded to the storage jar 700.

In embodiments, the implantable medical device 116 can be loaded intothe loading system 100. For example, the implantable medical device 116can be coupled to the device retainer 112, and the nosecone pin 114 canbe secured to the device retainer 112 by engaging the male threads 616of the nosecone pin 114 and the female threads 514 of the deviceretainer 112. The device retainer 112 including the implantable medicaldevice 116 and the nosecone pin 114 can be inserted into the loadingfunnel 108 and locking collar assembly 102 (attached to the loadingfunnel 108) to partially compress the implantable medical device 116.For example, the device retainer 112 can be inserted into the distalopening 306 of the loading funnel 108 and retracted through the loadingfunnel 108 into the loading channel 212 of the split collar 104. Thefunnel cap 110 can then be coupled to the loading funnel 108 by engagingthe female threads 408 of the funnel cap 110 with the male threads 308of the loading funnel 108.

Once the implantable medical device 116 is loaded into the loadingsystem 100, the loading system 100 may be stored for a period of timeuntil the implantable medical device 116 is utilized in a procedure. Assuch, the loading system 100 can be placed in the storage jar 700. Thestorage jar 700 can be filled with a preserving fluid 702. Thepreserving fluid 702 can be any type of fluid that maintains theintegrity and quality of the loading system 100. For example, if theimplantable medical device 116 include organic material, the preservingfluid 702 may include formaldehyde to maintain the integrity of theorganic material.

FIG. 8 and FIGS. 9A-91 illustrate an example of a process 800 for theoperation of the loading system 100 of FIGS. 1A and 1B to load theimplantable medical device into a delivery device. While FIG. Band FIGS.9A-91 illustrate various operations that can be performed in the process800, one skilled in the art will realize that existing operations can beremoved and additional operations can be added. Likewise, one skilled inthe art will realize that the order of the operations can be changed insome instances.

In step 802, the process 800 includes removing a loading system from astorage jar. For example, the loading system 100 may be stored in thestorage jar 700. The storage jar 700 can be unsealed and the loadingsystem 100 removed, for example as illustrated in FIG. 9A.

In step 804, the process 800 includes rinsing the loading system in asterile bath. For example, as illustrated in FIG. 9B, the loading system100 with the implantable medical device 116 loaded therein can be placedin a sterile bath 902. The sterile bath 902 can include any suitablefluid, e.g., saline, to sterilize the loading system 100 and removeunwanted materials from the loading system 100. For example, the sterilebath 902 can be utilized to remove any preserving fluid 702 from thestorage jar 700. When the loading system 100 is placed in the sterilebath 902 and agitated, the fluid of the sterile bath 902 wash theexterior of the loading system 100. Likewise, the fluid of the sterilebath 902 can enter the interior of the loading system 100, for example,through the ports 410, to wash the interior of the loading system 100and the implantable medical device 116.

In step 806, the process 800 includes attaching a delivery device to adevice retainer of the loading system. For example, as illustrated inFIG. 9C, a delivery device 904 can be attached to the device retainer112. The delivery device 904 can include an outer shaft and an innershaft that is disposed within a lumen of the outer shaft. The innershaft can include male threads located at a distal end thereof thatengage with the female threads 514 of the device retainer 112. The outershaft can be inserted into the split collar 104 of the locking collarassembly 102. The inner shaft can be extended from the outer shaft andcan be attached the device retainer 112, e.g., screwed into.

In step 808, the process 800 includes loading a valve into a capsule ofthe delivery device. In embodiments, the capsule can be the distalportion of the outer shaft of the delivery device 904. As illustrated inFIGS. 9D and 9E, the inner shaft can be retracted into the outer shaft.As the inner shaft is retracted, the device retainer 112 is alsoretracted into the outer shaft. Simultaneously, the implantable medicaldevice 116 attached to the device retainer 112 is retracted in theloading direction, L, through the loading funnel 108. As the implantablemedical device 116 moves through the compression volume 311, the innersurfaces of the loading funnel body 302 apply a compression force onsurfaces of the implantable medical device 116.

In step 810, the process 800 includes removing a loading funnel of theloading system. As illustrated in FIG. 9F, the loading funnel 108 can beremoved from the locking collar assembly 102. For example, the loadingfunnel 108 can be disengaged from the locking collar assembly 102. Thepartially compressed implantable medical device 116 exerts an outwardsspring force on the loading funnel 108, which pulls the loading funnel108 up against the locking collar assembly 102. This force may increaseduring loading until the locking collar assembly 102 exits the loadingfunnel 108 thereby releasing the loading funnel 108 from locking collarassembly 102.

In step 812, the process 800 includes removing a locking collar assemblyof the loading system. As illustrated in FIG. 9G, the locking collarassembly 102 can be removed from the delivery device 904 in a singleaction. For example, the locking collar assembly 102 can be slid off theouter shaft of the delivery device 904. Likewise, in another example,the locking collar 106 can be removed from the split collar 104, andthen the split collar 104 can be removed. For example, the split collar104 can be disengaged, e.g., unscrewed, from the locking collar 106, andthe split collar 104 can be separated into the first collar half 202 andthe second collar half 204.

In step 814, the process 800 includes attaching a nosecone to a noseconepin. For example, as illustrated in FIG. 9H, a nosecone 906 can beattached to the nosecone pin 114, for example, by engaging the malethreads 604 with female threads of the nosecone 906.

In step 816, the process 800 includes sealing the capsule. For example,as illustrated in FIG. 9I, the inner shaft can be further retracted intothe outer shaft until the nosecone 906 engages and creates a seal withthe outer shaft.

FIGS. 10A and 10B illustrate another example of a loading system 1000 inaccordance with an embodiment hereof. One skilled in the art willrealize that FIGS. 10A and 10B illustrate one example of a loadingsystem and that existing components illustrated in FIGS. 10A and 10B maybe removed and/or additional components may be added to the loadingsystem 1000.

As illustrated in FIG. 10A, the loading system 1000 includes a lockingcollar assembly 1002. The locking collar assembly 1002 includes a cap1004 and a locking collar 1006. The loading system 1000 also includes aloading funnel 1008 and an integrated storage jar 1010. As illustratedin FIG. 10B, the loading system 1000 includes a device retainer 1012 anda nosecone pin 1014. The device retainer 1012 secures an implantablemedical device 1016. When coupled to the loading system 1000, the deviceretainer 112 is positioned within the locking collar 1006 of the lockingcollar assembly 1002. The nosecone pin 1014 is coupled to the deviceretainer 1012 and extends through the loading funnel 1008. The loadingsystem 1000 also includes a fluid port 1018.

The device retainer 1012 is coupled to the implantable medical device1016. As described above, any type of implantable medical device thatrequires a conversion from an uncompressed state to a compressed stateand that requires loading onto a delivery device can be utilized withthe loading system 1000. In an embodiment, the implanted medical device1016 can include components that are intended to repair or supportsystems of the human body, e.g., prosthetic heart valves includingorganic tissue coupled to self-expandable or balloon-expandablestents/frames. For example, the loading system 1000 can be utilized onimplantable medical devices that are to be delivered transluminally,e.g., via a catheter, and need to be loaded onto or into a catheter. Thestent/frame may be radially compressed to have a low profile and loadedinto/onto a delivery device such that the heart valve prosthesis can bedelivered through the vessels to a target location in a compressedstate, and then expanded at the target location, by a self-expandingstent/frame or a balloon of the delivery device, for instance, toreplace the native heart valve.

The loading system 1000 is configured to store the implantable medicaldevice 1016 in a partially compressed or “loaded” state. That is, theloading funnel 1008 is configured to apply a force to the implantablemedical device 1016 to partially compress the implantable medical device1016 and maintain the implantable medical device 116 in the partiallycompressed state during storage. In embodiments, as further describedbelow, the loading funnel 1008 is formed with a tapered interior chamberthat maintains the implantable medical device 1016 in a partiallycompressed state and operates to further compress the implantablemedical device 1016 when loading the implantable medical device 1016onto a delivery device.

The locking collar assembly 1002 allows a delivery device, e.g.,catheter, to be attached to device retainer 1012 within minimalinteraction with the implantable medical device 1016. In embodiment, asfurther described below, a delivery device (or component of the deliverydevice) is inserted into the locking collar assembly 1002 and coupled tothe device retainer 1012. To load the implantable medical device 1016,the device retainer 1012 is retracted into the delivery device. As thedevice retainer 1012 is retracted, the implantable medical device 116 isfurther compressed by the loading funnel 1008.

While not described in further details, the device retainer 1012, thenosecone pin 1014, and the implantable medical device 1016 can includethe same components of device retainer 112, the nosecone pin 114, andimplantable medical device 116, respectively, as described above.

FIGS. 11A and 11B illustrate an example of a locking collar 1006 inaccordance with an embodiment hereof. One skilled in the art willrealize that FIGS. 11A and 11B illustrate one example of a lockingcollar and that existing components illustrated in FIGS. 11A and 11B maybe removed and/or additional components may be added to the lockingcollar 1006.

As illustrated in FIG. 11A, the locking collar 1006 includes a lockingcollar neck 1102 and a locking collar base 1104. The locking collar 1006includes a proximal opening 1106 located in the locking collar neck 1102and a distal opening 1108 located in the locking collar base 1104. Thelocking collar neck 1102 includes circular channels 1110. The circularchannel 1110 can be configured to receive sealing members, e.g.,O-rings, that provide a fluid seal between the locking collar neck 1102and the cap 1004.

As illustrated in FIG. 11B, the locking collar neck 1102 includes aloading channel 1112. The loading channel 1112 extends from the proximalopening 1106 to the top of the locking collar base 1104. The loadingchannel 1112 is formed in an approximate cylindrical shape with circularcross-section having an inner diameter, d₁. The loading channel 1112 isformed with the diameter, d₁, to accommodate the device retainer 1012and allow the insertion of a delivery device, e.g., catheter, into thelocking collar neck 1102. In embodiments, the diameter, d₁, of theloading channel 212 may depend on the FR size of the catheter. Forexample, the diameter, d₁, of the loading channel 212 may be formed toaccommodate a 18-33 Fr catheter. In an embodiment, the delivery devicemay be inserted into the proximal opening 1106, and the device retainer1012 may be positioned at or near the bottom of the locking collar neck1102. The locking collar 1006 can be formed of any suitable materialsuch as, but not limited to a polymeric material.

For example, the loading system 1000 may be configured to store and loada 42 millimeter (mm) TMVR device, e.g., heart valve and frame. In suchas embodiment, the loading channel 1112 may be formed with a diameter,d₁, in a range of approximately 6 mm to approximately 13 mm. In anotherexample, the loading system 1000 may be configured to store and load a48 mm TMVR device. In such an embodiment, the loading channel 1112 maybe formed with a diameter, d₁, in a range of approximately 6 mm toapproximately 13 mm. One skilled in the art will realize that theloading channel 1112 can be formed to any dimension and/orcross-sectional shape to accommodate different medical devices and ordelivery devices.

As illustrated in FIG. 11B, the locking collar neck 1102 also include acircular ridge 1113 positioned at a distal end of the loading channel1112. The circular ridge 1113 extends radially inward from the innersurface of the locking collar neck 1002. In an embodiment, the circularridge 1113 can be formed in an approximate ring and/or torus shape. Thecircular ridge 1113 is formed to a diameter, d₂, that is smaller thanthe diameter, d₁, of the loading channel 1112. In an embodiment, thecircular ridge 1113 can be formed to a diameter, d₂, that is larger thanthe diameter of the device retainer 1012, but smaller than the outerdiameter of the delivery device, e.g., an outer shaft of the deliverydevice, to be inserted into the locking collar neck 1102. In thisembodiment, the circular ridge 1113 can function as a stop that preventsthe delivery device from being inserted past the circular ridge 1113.

The locking collar base 1104 includes female threads 1114. The femalethreads 1114 are formed at a bottom portion of the locking collar base1104 adjacent to the distal opening 1108. The female threads 1114 areconfigured to engage with threads of the loading funnel 1008 (describedbelow in FIGS. 13A and 13B) to secure the loading funnel 1008 to thelocking collar 1006. The locking collar base 1104 also include a cavity1115. The cavity 1115 is formed of a first section 1116 that ispositioned adjacent to or near the distal opening 1108 and a secondsection 1118 that is positioned adjacent to or near the distal end ofthe loading channel 1112. The first section 1116 and the second section1118 are formed to a shape and dimension that matches the shape anddimensions of the loading funnel 1008, further described below.

FIGS. 12A and 12B illustrate an example of the cap 1004 in accordancewith an embodiment hereof. One skilled in the art will realize thatFIGS. 12A and 12B illustrate one example of a cap and that existingcomponents illustrated in FIGS. 12A and 12B may be removed and/oradditional components may be added to the cap 1004.

As illustrated in FIG. 12A, the cap 1004 includes a cap neck 1202 and acap base 1204. The cap neck 1202 is formed in an approximate rectangularpolygon shape. As illustrated in FIG. 12B, the cap base 1204 include acap opening 1206 that opens to a cap channel 1208. The cap channel 1208in an approximate cylindrical shape with circular cross-section having adiameter, c, that is approximately equal or larger than an outerdiameter of the cap neck 1202. For example, the cap channel 1208 mayhave the diameter, c, of approximately 15 mm and may have overall heightof approximately 40 mm. As illustrated in FIGS. 10A and 10B above, thecap 1004 slides over the cap neck 1202 to provide a fluid seal to theloading channel 1112, e.g., via sealing members disposed in the circularchannels 1110. The cap 1004 can be formed of any suitable material suchas, but not limited to a polymeric material.

FIGS. 13A and 13B illustrate an example of the loading funnel 1008 inaccordance with an embodiment hereof. One skilled in the art willrealize that FIGS. 13A and 13B illustrate one example of a loadingfunnel and that existing components illustrated in FIGS. 13A and 13B maybe removed and/or additional components may be added to the loadingfunnel 1008.

As illustrated in FIG. 13A, the loading funnel 1008 includes a firstsection 1302, a second section 1304, a third section 1306, a fourthsection 1308, and a fifth section 1310. The loading funnel 1008 includesa proximal opening 1312 and a distal opening 1314. The loading funnel1008 includes a ring 1316 that is formed at a proximal end of the secondsection 1304 and adjacent to and/or near the third section 1306. Thering 1316 is formed in a cylindrical shape that extends radially outwardfrom the outer surface of the second section 1304. The loading funnel1008 includes male threads 1318. The male threads 1318 are formed on thefirst section 1302 adjacent to and/or near the distal opening 1314. Themale threads 1318 are configured to engage with threads of theintegrated storage jar 1010 (described below in FIGS. 14A-14C) to securethe integrated storage jar 1010 to the loading funnel 1008. The ring1316 can operate as a stop or seal when the integrated storage jar 1010is attached to the loading funnel 1008. For example, the ring 1316 maycontain one or large o-ring seals that may prevent the liquid fromleaking out loading system 1000.

The loading funnel 1008 includes male threads 1320. The male threads1320 are formed on the fourth section 1308 adjacent to and/or near theproximal opening 1312. The male threads 1320 are configured to engagewith the female threads 1114 of the locking collar 1006 to secure theloading funnel 1008 to the locking collar 1006. The loading funnel 1008can be formed on any suitable material such as, but not limited tostainless steel.

The loading funnel 1008 is formed in an approximate conical shape withthe fifth section 1310 having a smaller diameter than the fourth section1308 and the fourth section having a smaller diameter than the firstsection 1302, the second section 1304, and the third section 1306. Asillustrated in FIG. 13B, the loading funnel 1008 forms a compressionvolume 1321 in the interior of the loading funnel 1008. The compressionvolume 1321 opens at the proximal opening 1312 and the distal opening1314. The compression volume 1321 is formed of a first chamber 1322, asecond chamber 1324, and a third chamber 1326. The proximal opening 1312is formed in the fifth section 1310 having a diameter, f₁. The distalopening 1314 is formed in the first section 1302 having a diameter, f₂.The interior of the loading funnel 1008 forms the compression volume1321. The compression volume 1321 is formed in an approximate funnel orcone shape with a decreasing volume from the first section 1302 to thefifth section 1310. In an embodiment, the compression volume 1321 istapered, in a decreasing diameter, from diameter, f₂, at the distalopening 1314 to the diameter, f₁, at the proximal opening 1312. Each ofthe first chamber 1322, the second chamber 1324, and the third chamber1326 can be formed in the shape of a funnel, each with a differentdegree of decreasing volume from the distal opening 1314 to the proximalopening 1312. In embodiments, the volume of the compression volume 1321operates to maintain the implantable medical device 1016 in a partiallycompressed state.

In embodiments, the degree of decreasing volume, e.g., taper angle, canaffect the angle at which the implant attachment tabs exit the funnel,with a longer taper improving the loading of the implantable medicaldevice 116. The longer taper may provide a smoother transition for theimplantable medical device 116 during loading into the delivery device.A short taper may apply compressive strain on the implantable medicaldevice 116, may require high force during loading, may result in anuneven crimp, may cause inflooding of the implantable medical device116, or may apply an additional compressive load on the implantablemedical device 116 when stored. According the degree of decreasingvolume, e.g., taper angle, may be set to minimize these and ensureintegrity of the implantable medical device 116.

In embodiments, the decreasing volume of the compression volume 1321also operates to apply a compression force on the implantable medicaldevice 1016 as device retainer 1012 is retracted through the loadingchannel 1112. That is, as the device retainer 1012 is retracted into thedelivery device positioned in the loading channel 1112, the implantablemedical device 1016 retracts in a loading direction, L, through theproximal opening 1312. As the implantable medical device 1016 movesthrough the compression volume 1321, the inner surfaces of the loadingfunnel 1008 apply a compression force on surfaces of the implantablemedical device 1016.

In embodiments, the diameter, f₁, of the proximal opening 1312 maydepend on the FR size of the catheter. For example, the diameter, f₁, ofthe proximal opening 1312 may be formed to accommodate a 18-33 Frcatheter. In embodiments, the diameter, f₂, of the distal opening 1314may depend on an outer diameter of the implantable medical device 116.

In some embodiments, the loading system 100 may be configured to storeand load a 42 mm TMVR device, and In such an embodiment, the diameter,f₁, can be in a range of approximately 6 mm to approximately 13 mm, andthe diameter, f₂, can be in the range of approximately 20 mm toapproximately 60 mm.

For example, the loading system 1000 may be configured to store and loada 42 mm TMVR device, and the proximal opening 1312 may be formed with adiameter, f₁, and the distal opening 1314 may be formed with a diameter,f₂. In such an embodiment, the diameter, f₁, can be in a range ofapproximately 6 mm to approximately 13 mm, and the diameter, f₂, can bein the range of approximately 20 mm to approximately 60 mm. In anotherexample, the loading system 1000 may be configured to store and load a48 mm TMVR device, and the proximal opening 1312 may be formed with adiameter, f₁, and the distal opening 1314 may be formed with a diameter,f₂. In such an embodiment, the diameter, can be in a range ofapproximately 6 mm to approximately 13 mm, and the diameter, f₂, can bein the range of approximately 20 mm to approximately 60 mm. One skilledin the art will realize that the compression volume 1321 can be formedto any dimension and/or cross-sectional shape to accommodate differentmedical devices and or delivery devices.

While FIGS. 11A, 11B, 13A, and 13B illustrate threads for coupling thelocking collar 1006 and the loading funnel 1008, one skilled in the artwill realize that other types of connectors can be utilized tomechanically couple the locking collar 1006 and the loading funnel 1008.In some embodiments, the locking collar 1006 and the loading funnel 1008can include a push fit locking collar that acts as an interference fitfor coupling the locking collar 1006 and the loading funnel 1008. Forexample, an outer diameter of the locking collar 1006 may be larger thanan inner diameter of the loading funnel 1008. In some embodiments, thelocking collar 1006 and the loading funnel 1008 can include a c-clipmechanism connector that acts as a mechanical interference between thelocking collar 1006 and the loading funnel 1008. In some embodiments,the locking collar 1006 and the loading funnel 1008 can include a snapfit connection (e.g., cantilever, torsional and/or annular). Forexample, the locking collar 1006 can include a protruding edge or tab,and the loading funnel 1008 can include a snap-in area (e.g., groove,channel, etc.) for receiving and locking the protruding edge or tab.Likewise, for example, the loading funnel 1008 can include a protrudingedge or tab, and the locking collar 1006 can include a snap-in area(e.g., groove, channel, etc.) for receiving and locking the protrudingedge or tab.

FIGS. 14A-14C illustrate an example of the integrated storage jar 1010in accordance with an embodiment hereof. One skilled in the art willrealize that FIGS. 14A-14C illustrate one example of an integratedstorage jar and that existing components illustrated in FIGS. 14A-14Cmay be removed and/or additional components may be added to theintegrated storage jar 1010.

As illustrated in FIG. 14A, the integrated storage jar 1010 includes ajar body 1402. The jar body 1402 is formed with an approximatecylindrical shape. The jar body 1402 includes a proximal opening 1404and a distal opening 1406. The integrated storage jar 1010 includesfemale threads 1408. The female threads 1408 are formed at the proximalend of the jar body 1402 adjacent to or near the proximal opening 1404.The female threads 1408 are configured to engage with the male threads1318 of the loading funnel 1008 to secure the integrated storage jar1010 to the loading funnel 1008. The integrated storage jar 1010 can beformed of any suitable material such as, but not limited to a polymericmaterial.

The integrated storage jar 1010 includes a jar base 1410. The jar base1410 includes an opening 1412. The opening 1412 is configured to receivethe fluid port 1018. When the fluid port 1018 is inserted into theopening 1412, the jar base 1410 forms a fluid chamber 1413. The fluidchamber 1413 is configured to hold and maintain fluids within theloading system 1000, for example, preservation fluids and/or sterilefluids.

The integrated storage jar 1010 includes a nosecone pin holder 1414. Thenosecone pin holder 1414 is configured to receive the nosecone pin 1014and secure the nosecone pin 1014 in place when the integrate storage jar1010 is attached to the loading funnel 1008. The nosecone pin holder1414 is formed in an approximate cylindrical shape. The nosecone pinholder 1414 is configured to hold the nosecone pin 1014 in place andprevent movement of the nosecone pin 1014. That is, when the noseconepin 114 is stored within the loading system 1000, the nosecone pin 114abuts a bottom surface of the nosecone pin holder 1414. The sidewalls ofthe nosecone pin holder 1414 hold the nosecone pin 114 in position andprevent the nosecone pin 114 from moving laterally within the loadingsystem 1000.

In embodiments, the nosecone pin holder 1414 operates to prevent thedevice retainer 1012 and the implantable medical device 1016 fromexiting the distal opening 1314 of the loading funnel 1008. That is, thenosecone pin holder 1414 (e.g., bottom surface) applies a force on thenosecone pin 1014, which is attached to the device retainer 1012, toprevent the device retainer 1012 and the implantable medical device 1016from sliding out of the loading funnel 1008 due to compression force ofthe loading funnel 1008 when the implantable medical device 1016 is in apartially compressed state.

While FIGS. 13A, 13B, and 14A-14C illustrate threads for coupling theloading funnel 1008 and the integrated storage jar 1010, one skilled inthe art will realize that other types of connectors can be utilized tomechanically couple the loading funnel 1008 and the integrated storagejar 1010. In some embodiments, the loading funnel 1008 and theintegrated storage jar 1010 can include a push fit locking collar thatacts as an interference fit for coupling the loading funnel 1008 and theintegrated storage jar 1010. For example, an outer diameter of theloading funnel 1008 may be larger than an inner diameter of theintegrated storage jar 1010. In some embodiments, the loading funnel1008 and the integrated storage jar 1010 can include a c-clip mechanismconnector that acts as a mechanical interference between the loadingfunnel 1008 and the integrated storage jar 1010. In some embodiments,the loading funnel 1008 and the integrated storage jar 1010 can includea snap fit connection (e.g., cantilever, torsional and/or annular). Forexample, the loading funnel 1008 can include a protruding edge or tab,and the integrated storage jar 1010 can include a snap-in area (e.g.,groove, channel, etc.) for receiving and locking the protruding edge ortab. Likewise, for example, the integrated storage jar 1010 can includea protruding edge or tab, and the loading funnel 1008 can include asnap-in area (e.g., groove, channel, etc.) for receiving and locking theprotruding edge or tab.

FIGS. 15A and 15B illustrate an example of the fluid port 1018 inaccordance with an embodiment hereof. One skilled in the art willrealize that FIGS. 15A and 15B illustrate one example of a fluid portand that existing components illustrated in FIGS. 15A and 15B may beremoved and/or additional components may be added to the fluid port1018.

In embodiments, the fluid port 1018 can operate as a luer connector toallow for syringe attachment. As illustrated in FIG. 15A, the fluid port1018 includes a port base 1502 and a port neck 1504. The port base 1502is formed in an approximate cylindrical shape and includes a proximalopening 1506 formed at a proximal end of the fluid port 1018. The portneck includes a distal opening 1508 formed at a distal end of the portneck. The port base 1502 includes a first base section 1510 that isformed adjacent to the proximal end of the fluid port 1018 and a secondbase section 1512 that is formed adjacent to the first base section 1510and the distal end of the port base 1502. The port base 1502 alsoincludes ridges 1514. The ridges 1514 operate to secure the fluid port1018 into the opening 1412 of the integrated storage jar 1010. Forexample, the ridges 1514 can secure the fluid port 1018 into the opening1412 via a friction force. In other embodiments, the fluid port 1018 canbe secured to the opening 1412 using other types of connections such asadhesive, weld bond, or threaded/screw connection.

The port neck 1504 includes a first neck section 1516 that is formedadjacent to the port base 1502, a second neck section 1518 that isformed adjacent to the first neck section 1516, and a third neck section1520 that is formed adjacent to the second neck section 1518 and thedistal end of the fluid port 1018. Each of the first neck section 1516,second neck section 1518, and third neck section 1520 are formed in anapproximate cylindrical shape.

As illustrated in FIG. 15B, the fluid port 1018 includes a fluid channel1522. The fluid channel 1522 extends from the proximal opening 1506 tothe distal opening 1508. The fluid channel 1522 allows fluid to beinjected for extracted from the loading system 1000. For example, afluid delivery device, e.g., syringe, can be attached to the fluid port1018 to extract and inject fluids.

In embodiments, the implantable medical device 1016 can be loaded intothe loading system 1000. For example, the implantable medical device1016 can be coupled to the device retainer 1012, and the nosecone pin1014 can be secured to the device retainer 1012 by engaging the malethreads of the nosecone pin 1014 and the female threads of the deviceretainer 1012. The device retainer 1012 including the implantablemedical device 1016 and the nosecone pin 1014 can be inserted into theloading funnel 1008 and locking collar assembly 1002 (attached to theloading funnel 1008) to partially compress the implantable medicaldevice 1016. For example, the device retainer 1012 can be inserted intothe distal opening 1314 of the loading funnel 1008 and retracted throughthe loading funnel 1008 into the loading channel 1112 of the lockingcollar 1006. The integrate storage jar 1010 can then be coupled to theloading funnel 1008 by engaging the female threads 1408 of the integratestorage jar 1010 with the male threads 1318 of the loading funnel 1008.

In embodiments, once the implantable medical device 1016 is loaded intothe loading system 1000, the loading system 1000 may be stored for aperiod of time until the implantable medical device 1016 is utilized ina procedure. The loading system 100 can be filed with a preserving fluidvia the fluid port 1018 in the integrated storage jar 1010. Thepreserving fluid can be any type of fluid that maintains the integrityand quality of the loading system 1000. For example, if the implantablemedical device 1016 include organic material, the preserving fluid mayinclude formaldehyde to maintain the integrity of the organic material.

FIG. 16 and FIGS. 17A-17I illustrate an example of a process 1600 forthe operation of the loading system 1600 of FIGS. 10A and 10B forloading an implantable medical device into a delivery system. While FIG.16 and FIGS. 17A-17I illustrate various operations that can be performedin the process 1600, one skilled in the art will realize that existingoperations can be removed and additional operations can be added.Likewise, one skilled in the art will realize that the order of theoperations can be changed.

In 1602, the process 1600 includes removing a cap from a loading system.For example, as illustrated in FIGS. 17A and 17B, the cap 1004 can beremoved from the loading system 1000. For example, a force can beapplied to the cap 1004 to extract the cap 1004 from the locking collarneck 1102.

In 1604, the process 1600 includes attaching a fluid source to a fluidport of the loading system. In 1606, the process 1600 includes flushingthe loading system with a sterile solution. For example, as illustratedin FIG. 17C, a syringe 1702 can be attached to the fluid port 1018 ofthe loading system 1000. The syringe 1702 can then be operated tointroduce a sterile solution, e.g., saline, into the loading system 1000via the fluid channel 1522. The saline can replace the preserving fluidcontained with the loading system and wash the interior of the loadingsystem 1000.

In 1608, the process 1600 includes attaching a delivery device to adevice retainer of the loading system. For example, as illustrated inFIG. 17D, a delivery device 1704 can be attached to the device retainer1012. The delivery device 1704 can include an outer shaft and an innershaft that retracts into a lumen of the inner shaft. The inner shaft caninclude male threads that engage with the female threads of the deviceretainer 1012. The outer shaft can be inserted into the locking collarneck 1102. The inner shaft can be extended from the outer shaft and canbe attached the device retainer 1012, e.g., screwed into.

In 1610, the process 1600 includes loading the valve into a capsule ofthe delivery device. In embodiments, the capsule can be the distalportion of the outer shaft of the delivery device 1704. As illustratedin FIGS. 17E and 17G, the inner shaft can be retracted into the outershaft. As the inner shaft is retracted, the device retainer 1012 is alsoretracted into the outer shaft. Simultaneously, the implantable medicaldevice 1016 is retracted in the loading direction, L, through theloading funnel 1008. As the implantable medical device 1016 movesthrough the compression volume 1321, the inner surfaces of the loadingfunnel 1008 apply a compression force on surfaces of the implantablemedical device 1016. As the inner shaft is retracted, additional sterilesolution may be injected into the loading system 1000 with the syringe1702.

In 1612, the process 1600 includes removing the locking collar, theloading funnel, and the storage jar. As illustrated in FIG. 17 lockingcollar neck 1102, e.g., sliding the outer shaft from the locking collarneck 1102.

In 1614, the process 1600 includes attaching a nosecone to a noseconepin. For example, as illustrated in FIG. 17H, a nosecone 1706 can beattached to the nosecone pin, for example, by engaging the male threadswith female threads of the nosecone 1706.

In 1616, the process 1600 includes sealing the capsule of the deliverydevice. For example, as illustrated in FIG. 17I, the inner shaft can befurther retracted into the outer shaft until the nosecone 1706 engagesand creates a seal with the outer shaft.

Additional discussion of various embodiments is presented below:

Embodiment 1 is a device for storing medical devices and loading themedical devices onto delivery devices. The device includes a lockingcollar assembly including a proximal end, a distal end, and a loadingchannel formed between the proximal end and the distal end. The devicealso includes a loading funnel coupled to the distal end of the lockingcollar assembly at a proximal end of the loading funnel. The loadingfunnel is configured to store a collapsible medical device within atapered interior volume of the loading funnel in a partially collapsedstate. The tapered interior volume decreases in volume from a distal endof the loading funnel to the proximal end of the loading funnel. Thedevice includes a retainer positioned with the loading channel at thedistal end of the locking collar assembly and includes a connectorconfigured to couple to a delivery device. The collapsible medicalappliance is coupled to the retainer. The retainer maintains thecollapsible medical device within the loading funnel prior to connectionto the delivery device. The device further includes a nosecone pincoupled to the retainer and positioned within the tapered interiorvolume of the loading funnel. Additionally, the device includes astorage jar coupled to a distal end of the loading funnel. The storagejar is configured retain the collapsible medical device and the noseconepin within the tapered interior volume of the loading funnel.

Embodiment 2 includes the device of embodiment 1, and further includes acap removably coupled to locking collar assembly, wherein the cap andthe storage jar maintain fluids within an interior volume of the of thestorage jar, the tapered interior volume of the loading funnel, and theloading channel of the locking collar assembly.

Embodiment 3 includes the device embodiment 2, wherein the lockingcollar assembly includes: a locking collar neck configured to receivethe cap; and a locking collar body comprising female threads formed onan interior surface of the locking collar body.

Embodiment 4 includes the device of embodiment 3, wherein the loadingfunnel includes: male threads formed at the proximal end of the loadingfunnel, wherein the male threads are configured to engage the femalethreads of the locking collar body, and male threads formed at thedistal end of the loading funnel.

Embodiment 5 includes the device of embodiment 4, wherein the storagejar includes: female threads formed at a proximal end of the storagejar, wherein the female threads are configured to engage the malethreads formed at the distal end of the loading funnel to secure thestorage jar to the loading funnel; and one or more fluid portsconfigured to selectively allow fluid to flow into and out of aninterior volume of the storage jar and the loading funnel.

Embodiment 6 includes the device of any of embodiments 1-5, wherein thetapered interior volume comprises an approximate conical shape.

Embodiment 7 includes the device of any of embodiments 1-6, wherein theconnector of the retainer comprises female threads configured to engagemale threads of the delivery device.

Embodiment 8 includes the device of any of embodiments 1-7, wherein thecollapsible medical device is an expanding frame containing a heartvalve.

Embodiment 9 is a device for storing medical devices and loading themedical devices onto delivery devices. The device includes a lockingcollar assembly including a proximal end, a distal end, and a loadingchannel formed between the proximal end and the distal end. The devicealso includes a loading funnel coupled to the distal end of the lockingcollar assembly at a proximal end of the loading funnel. The loadingfunnel is configured to store a collapsible medical device in apartially collapsed state within a tapered interior volume of theloading funnel. The tapered interior volume decreases in volume from adistal end of the loading funnel to the proximal end of the loadingfunnel. Further, the device includes a retainer positioned with theloading channel at the distal end of the locking collar assembly andincludes a connector configured to couple to a delivery device. Thecollapsible medical device is coupled to the retainer. The retainermaintains the collapsible medical device within the loading funnel priorto connection to the delivery device. The device includes a nosecone pincoupled to the retainer and positioned within the tapered interiorvolume of the loading funnel. Additionally, the device includes a funnelcap coupled to the distal end of the loading funnel. The funnel cap isconfigured retain the collapsible medical device and the nosecone pinwithin the tapered interior volume of the loading funnel.

Embodiment 10 includes the device of embodiment 9, wherein the lockingcollar assembly includes: a split locking collar comprising a firstcollar half and a second collar half; and a locking collar removablycoupled to distal portions of the first collar half and the secondcollar half, wherein the locking collar secures the first collar halfand the second collar half to the loading funnel to define the loadingchannel.

Embodiment 11 includes the device of any of embodiments 9-10, whereinthe tapered interior volume comprises an approximate conical shape.

Embodiment 12 includes the device of any of embodiments 9-11, whereinthe loading funnel includes male threads formed at the distal end of theloading funnel.

Embodiment 13 includes the device of embodiment 12, wherein the funnelcap includes: female threads formed at a proximal end of the funnel cap,wherein the female threads are configured to engage the male threads ofthe loading funnel to secure the funnel cap to the loading funnel; andone or more fluid ports configured to allow fluid to flow into and outof an interior volume of the loading cap and the loading funnel.

Embodiment 14 includes the device of any of embodiments 9-13, whereinthe connector of the retainer comprises female threads configured toengage male threads of the delivery device.

Embodiment 15 includes the device of any of embodiments 9-14, whereinthe collapsible medical device is an expanding frame containing a heartvalve.

Embodiment 16 includes the device of any of embodiments 9-15, whereinthe device is configured to be maintained with a storage jar containinga preserving fluid.

Embodiment 17 is a method for storing medical devices and loading themedical devices onto delivery devices, The method includes washing, witha sterile solution, a collapsible medical device that is stored within atapered interior volume of a loading device in a partially collapsedstate. The method also includes coupling a delivery device to a retainerpositioned within the loading device. The retainer maintains thecollapsible medical device within the loading device in the partiallycollapsed state prior to connection to the delivery device.Additionally, the method includes retracting the retainer through aloading channel of the loading device, where retracting retainer causesthe collapsible medical device to move through the tapered interiorvolume to compress the collapsible medical device. The method includesremoving the loading device from the delivery device. The method alsoincludes sealing the collapsible medical device within the deliverydevice.

Embodiment 18 includes the method of embodiment 17, wherein washing thecollapsible medical device includes: connecting a fluid delivery deviceto a fluid port of the loading device; and engaging the fluid deliverydevice to flow the sterile fluid into the loading system.

Embodiment 19 includes the method of any of embodiments 17-18, whereinwashing the collapsible medical device includes submerging the loadingsystem within bath comprising the sterile fluid, wherein the loadingsystem comprises one or more fluid ports configured to allow the sterilefluid to flow into and out of the loading device.

Embodiment 20 includes the method of any of embodiments 17-19, whereinsealing the collapsible medical device within the delivery devicecomprises attaching a nosecone to a nosecone pin coupled to theretainer.

It should be understood that various embodiments disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single device or component forpurposes of clarity, it should be understood that the techniques of thisdisclosure may be performed by a combination of devices or componentsassociated with, for example, a medical device.

What is claimed is:
 1. A device for storing medical devices and loadingthe medical devices onto delivery devices, the device comprising: alocking collar assembly comprising a proximal end, a distal end, and aloading channel formed between the proximal end and the distal end; aloading funnel coupled to the distal end of the locking collar assemblyat a proximal end of the loading funnel, wherein the loading funnel isconfigured to store a collapsible medical device within a taperedinterior volume of the loading funnel in a partially collapsed state,and wherein the tapered interior volume decreases in volume from adistal end of the loading funnel to the proximal end of the loadingfunnel; a retainer positioned with the loading channel at the distal endof the locking collar assembly and comprising a connector configured tocouple to a delivery device, wherein the collapsible medical applianceis coupled to the retainer, and wherein the retainer maintains thecollapsible medical device within the loading funnel prior to connectionto the delivery device; a nosecone pin coupled to the retainer andpositioned within the tapered interior volume of the loading funnel; anda storage jar coupled to a distal end of the loading funnel, wherein thestorage jar is configured retain the collapsible medical device and thenosecone pin within the tapered interior volume of the loading funnel.2. The device of claim 1, the device further comprising: a cap removablycoupled to locking collar assembly, wherein the cap and the storage jarmaintain fluids within an interior volume of the of the storage jar, thetapered interior volume of the loading funnel, and the loading channelof the locking collar assembly.
 3. The device of claim 2, wherein thelocking collar assembly comprises: a locking collar neck configured toreceive the cap; and a locking collar body comprising female threadsformed on an interior surface of the locking collar body.
 4. The deviceof claim 3, wherein the loading funnel comprises: male threads formed atthe proximal end of the loading funnel, wherein the male threads areconfigured to engage the female threads of the locking collar body, andmale threads formed at the distal end of the loading funnel.
 5. Thedevice of claim 4, wherein the storage jar comprises: female threadsformed at a proximal end of the storage jar, wherein the female threadsare configured to engage the male threads formed at the distal end ofthe loading funnel to secure the storage jar to the loading funnel; andone or more fluid ports configured to selectively allow fluid to flowinto and out of an interior volume of the storage jar and the loadingfunnel.
 6. The device of claim 1, wherein the tapered interior volumecomprises an approximate conical shape.
 7. The device of claim 1,wherein the connector of the retainer comprises female threadsconfigured to engage male threads of the delivery device.
 8. The deviceof claim 1, wherein the collapsible medical device is an expanding framecontaining a heart valve.
 9. A device for storing medical devices andloading the medical devices onto delivery devices, the devicecomprising: a locking collar assembly comprising a proximal end, adistal end, and a loading channel formed between the proximal end andthe distal end; a loading funnel coupled to the distal end of thelocking collar assembly at a proximal end of the loading funnel, whereinthe loading funnel is configured to store a collapsible medical devicein a partially collapsed state within a tapered interior volume of theloading funnel, and wherein the tapered interior volume decreases involume from a distal end of the loading funnel to the proximal end ofthe loading funnel; a retainer positioned with the loading channel atthe distal end of the locking collar assembly and comprising a connectorconfigured to couple to a delivery device, wherein the collapsiblemedical device is coupled to the retainer, and wherein the retainermaintains the collapsible medical device within the loading funnel priorto connection to the delivery device; a nosecone pin coupled to theretainer and positioned within the tapered interior volume of theloading funnel; and a funnel cap coupled to the distal end of theloading funnel, wherein the funnel cap is configured retain thecollapsible medical device and the nosecone pin within the taperedinterior volume of the loading funnel.
 10. The device of claim 9,wherein the locking collar assembly comprises: a split locking collarcomprising a first collar half and a second collar half; and a lockingcollar removably coupled to distal portions of the first collar half andthe second collar half, wherein the locking collar secures the firstcollar half and the second collar half to the loading funnel to definethe loading channel.
 11. The device of claim 9, wherein the taperedinterior volume comprises an approximate conical shape.
 12. The deviceof claim 9, wherein the loading funnel comprises: male threads formed atthe distal end of the loading funnel.
 13. The device of claim 12,wherein the funnel cap comprises: female threads formed at a proximalend of the funnel cap, wherein the female threads are configured toengage the male threads of the loading funnel to secure the funnel capto the loading funnel; one or more fluid ports configured to allow fluidto flow into and out of an interior volume of the loading cap and theloading funnel.
 14. The device of claim 9, wherein the connector of theretainer comprises female threads configured to engage male threads ofthe delivery device.
 15. The device of claim 9, wherein the collapsiblemedical device is an expanding frame containing a heart valve.
 16. Thedevice of claim 9, wherein the device is configured to be maintainedwith a storage jar containing a preserving fluid.
 17. A method forstoring medical devices and loading the medical devices onto deliverydevices, the method comprising: washing, with a sterile solution, acollapsible medical device that is stored within a tapered interiorvolume of a loading device in a partially collapsed state; coupling adelivery device to a retainer positioned within the loading device,wherein the retainer maintains the collapsible medical device within theloading device in the partially collapsed state prior to connection tothe delivery device; retracting the retainer through a loading channelof the loading device, wherein retracting retainer causes thecollapsible medical device to move through the tapered interior volumeto compress the collapsible medical device; removing the loading devicefrom the delivery device; and sealing the collapsible medical devicewithin the delivery device.
 18. The method of claim 17, wherein washingthe collapsible medical device comprises: connecting a fluid deliverydevice to a fluid port of the loading device; and engaging the fluiddelivery device to flow the sterile fluid into the loading system. 19.The method of claim 17, wherein washing the collapsible medical devicecomprises: submerging the loading system within bath comprising thesterile fluid, wherein the loading system comprises one or more fluidports configured to allow the sterile fluid to flow into and out of theloading device.
 20. The method of claim 17, wherein sealing thecollapsible medical device within the delivery device comprisesattaching a nosecone to a nosecone pin coupled to the retainer.